0.5 mg hard anagrelide capsules

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Anagrelide AOP is and what it is used for 
2. What you need to know before taking Anagrelide AOP 
3. How to take Anagrelide AOP 
4. Possible side effects 
5. How to store Anagrelide AOP 
6. Contents of the packaging and other information 

1. What Anagrelide AOP is and what it is used for

Anagrelide AOP contains the active substance anagrelide. Anagrelide AOP is a drug that inhibits the development of platelets in the bone marrow.

Anagrelide AOP is used to reduce the number of platelets in patients with essential thrombocythemia (which is a disease in which the bone marrow forms too many platelets ). Too high a platelet count can cause problems with blood circulation and the blood’s ability to coagulate. By lowering the number of platelets, the risk of serious health problems is reduced.

Anagrelide contained in Anagrelide AOP may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Anagrelide AOP

Do not take Anagrelide AOP

  • if you are allergic to anagrelide or any of the other ingredients of this medicine (listed in section 6)
  • if you have a serious heart condition
  • if you have severe kidney problems
  • if you have moderate to severe liver problems.

Warnings and cautions

Talk to your doctor before taking Anagrelide AOP:

  • if you have or think you have heart disease
  • if you were born with a prolonged QT interval (seen on ECG, electrical recording of the heart) or if it is present in your family, or if you are taking other medicines that lead to abnormal ECG changes, or if you have low levels of electrolytes, for example, potassium, magnesium or calcium (see section “Other medicines and Anagrelide AOP”)
  • if you have kidney or liver disease.

Children and young people

There is only limited experience in the use of anagrelide in children and adolescents. Your doctor will decide if treatment with Anagrelide AOP is right for you.

Other medicines and Anagrelide AOP

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

  • Drugs that can change the heart rhythm
  • Certain types of antibiotics used to treat infections, e.g. enoxacin
  • Fluvoxamine used to treat depression
  • Certain types of drugs used to reduce the amount of acid produced in the stomach, e.g. omeprazole
  • Theophylline used to treat lung diseases such as asthma
  • Drugs used to treat heart disease, e.g. milrinone, enoximone, amrinone, olprinone, and cilostazol
  • Drugs that affect the platelets, e.g. acetylsalicylic acid (concomitant use of acetylsalicylic acid and Anagrelide AOP may increase bleeding tendency)
  • In some patients, this medicine may cause indigestion (eg diarrhea) and may make birth control pills less effective.

Anagrelide AOP with food and drink

Grapefruit juice can prolong the time it takes for this medicine to leave the body. It is recommended that you do not drink grapefruit juice while taking Anagrelide AOP.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Anagrelide AOP should not be taken during pregnancy.

During treatment with Anagrelide AOP, fertile women should use an effective contraceptive.

Anagrelide AOP should not be used during breast-feeding. You should stop breast-feeding if you are taking this medicine.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Do not drive or use machines if you feel dizzy after taking Anagrelide AOP.

Anagrelide AOP contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Anagrelide AOP

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will prescribe the dose that is best for you. The usual starting dose of Anagrelide AOP is 1 capsule to 2 capsules per day for at least one week. Then your doctor can either increase or decrease the number of capsules you take to find the dose that is best for you and that treats your condition most effectively. The maximum dose is 10 capsules per day.

If you have liver or kidney disease, your doctor will decide if you will be treated with Anagrelide AOP.

Anagrelide AOP capsules should be swallowed whole with some water. The capsules should not be crushed or dissolved in any liquid. You can take the capsules with food, after a meal, or on an empty stomach. You should preferably take the capsules at the same time each day.

If you forget to take Anagrelide AOP

If you forget to take your capsules at the prescribed time, take them as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Anagrelide AOP

Do not stop taking this medicine without first consulting your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Anagrelide AOP and contact a doctor or see your nearest emergency department immediately if you experience any of the following symptoms:

Uncommon (may affect up to 1 in 100 people):

  • signs that include severe chest pain and shortness of breath ( heart failure )
  • signs that include very rapid heartbeat, and severe chest pain associated with shortness of breath ( ventricular arrhythmia )
  • Signs include shortness of breath, swelling of the legs and ankles, and bluish discoloration of the skin and lips (pulmonary hypertension).

Rare (may affect up to 1 in 1,000 people):

  • signs that include severe chest pain and shortness of breath (heart attack)
  • signs that include very rapid heartbeat and severe chest pain associated with shortness of breath ( atrial fibrillation )
  • signs that include severe chest pain due to insufficient blood flow to the heart (angina).

Other side effects that may occur:

Very common side effects (may affect more than 1 in 10 people):

  • headache

Common side effects (may affect up to 1 in 10 people):

  • decreased number of red blood cells ( anemia ), local bleeding in the skin
  • fluid retention ( edema )
  • dizziness ( vertigo ), tingling and ant crawling, insomnia
  • irregular heartbeat (palpitations), rapid heartbeat ( tachycardia ), high blood pressure
  • nosebleeds
  • nausea, diarrhea, indigestion
  • itchy and/or reddening skin
  • back pain
  • weakness or fatigue

Uncommon side effects (may affect up to 1 in 100 people):

  • decreased platelet count, bleeding, bruising
  • weight gain
  • depression, nervousness, dry mouth, migraine
  • visual disturbances, eye infection
  • ringing in the ears ( tinnitus )
  • cardiac arrhythmia, circulatory failure
  • shortness of breath, respiratory infection
  • vomiting, gas ( flatulence ), constipation, abdominal pain
  • hair loss, itching
  • muscle and joint pain
  • renal impairment, urinary tract infection
  • pain, weakness

Rare side effects (may affect up to 1 in 1,000 people):

  • low blood pressure
  • fluid accumulation around or in the lungs, lung infection, asthma
  • inflammation of the stomach, eating disorders
  • rash
  • increased need to urinate at night
  • elevated liver enzymes
  • flu-like symptoms, chills, general discomfort

Has been reported (occurs in an unknown number of users):

  • torsades de pointes (potentially life-threatening, irregular heartbeat)
  • pulmonary fibrosis (inflammation of the lungs that can cause scarring of the lungs)
  • renal inflammation (tubulointerstitial nephritis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Anagrelide AOP

Keep this medicine out of the sight and reach of children.

Do not store above 30 ° C. Store in the original package. Sensitive to light.

The medicine should be used within 100 days after opening the jar.

Do not use this medicine after the expiry date which is stated on the carton and can label after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is anagrelide.

One hard capsule contains anagrelide hydrochloride monohydrate equivalent to 0.5 mg anagrelide.

Other ingredients are:

Capsule content: lactose monohydrate, povidone K30, crospovidone type A, microcrystalline cellulose (E460), magnesium stearate (E470b)

Capsule shell: titanium dioxide (E171), indigo carmine (E132), gelatin, water

What the medicine looks like and the contents of the pack

Anagrelide AOP is supplied as blue hard capsules approximately 14.3 mm long, filled with a white powder.

Anagrelide AOP is supplied in polyethylene cans with child-resistant, safety-sealed polypropylene lids with desiccant. The jar contains 100 blue capsules.

Marketing Authorization Holder and Manufacturer

AOP Orphan Pharmaceuticals AG

Wilhelminenstraße 91 / II f

1160 Vienna

Austria

This medicinal product is authorized under the European Economic Area under the names:

Austria Anagrelide AOP 0.5 mg Heart Capsules
Bulgaria anagrelide AOP 0.5 mg Capsules, Verdi
Czech Republic Anagrelid AOP
Germany Anagrelide AOP 0.5 mg Heart Capsules
Denmark Anagrelid AOP
Estonia Anagrelide AOP
Finland Anagrelide AOP 0.5 mg covate capsule
France ANAGRELIDE AOP
Latvia Anagrelide AOP 0.5 mg is a capsule
Norway Anagrelide AOP
Poland Anagrelidum AOP
Romania Anagrelidă AOP 0.5mg capsule
Slovenia Anagrelide AOP Orphan 0.5 mg third capsule
Slovakia Anagrelide AOP 0.5 mg tvrdé capsule

Muhammad Nadeem

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